FDA recall D-1138-2016

Product

Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com

Reason for recall

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-15

Report date

2016-07-13

Termination date

2020-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jewett, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1138-2016